UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019272
Receipt number R000022202
Scientific Title Efficacy and safety of Mirabegron for treatment OAB in the postmenopausal female patients -Evaluation using Pressure Flow Study
Date of disclosure of the study information 2015/10/08
Last modified on 2015/10/08 08:05:48

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Basic information

Public title

Efficacy and safety of Mirabegron for treatment OAB in the postmenopausal female patients -Evaluation using Pressure Flow Study

Acronym

Efficacy of Mirabegron using Pressure Flow Study

Scientific Title

Efficacy and safety of Mirabegron for treatment OAB in the postmenopausal female patients -Evaluation using Pressure Flow Study

Scientific Title:Acronym

Efficacy of Mirabegron using Pressure Flow Study

Region

Japan


Condition

Condition

overactive bladder

Classification by specialty

Urology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Efficacy and safety of Mirabegron for treatment OAB using Urodynamic Study

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV


Assessment

Primary outcomes

the change of storage and voiding function before and after administration

Key secondary outcomes

the change of subjective symptom (IPSS, OABSS) before and after administration


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Mirabegron 50mg/day for 12 weeks

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

50 years-old <=

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

Inclusion criteria were as follows: total OAB symptom scores (OABSS) of 3; urgency episodes 1 per week; post-menopausal women; and age 50 years.

Key exclusion criteria

Patients were excluded if they received oral anticholinergic agents, alpha1-blockers, antidepressants, or anti-anxiety agents; had obvious neurogenic bladder dysfunction, bladder calculi, or active urinary tract infection; or had severe cardiac disease, renal dysfunction (serum-creatinine;2 mg/dL), and/or hepatic dysfunction (i.e., aspartate aminotransferase and alanine aminotransferase levels of more than twice the normal value).

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshihisa Matsukawa

Organization

Nagoya University Graduate School of Medicine

Division name

Urology

Zip code


Address

65 tsurumai, Showa-ku, Nagoya

TEL

+81-52-744-2985

Email

yoshi44@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yoshihisa Matsukawa

Organization

Nagoya University Graduate School of Medicine

Division name

Urology

Zip code


Address

65 tsurumai, Showa-ku, Nagoya

TEL

+81-52-744-2985

Homepage URL


Email

yoshi44@med.nagoya-u.ac.jp


Sponsor or person

Institute

Department of Urology
Nagoya University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Urology
Nagoya University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

名古屋大学医学部附属病院泌尿器科


Other administrative information

Date of disclosure of the study information

2015 Year 10 Month 08 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

A total of 60 patients with a mean age of 72.3 years (50-86 years) were included in the analysis. The subjective symptom parameter (i.e., the mean OABSS score) decreased significantly from 9.4 to 6.2 points (p < 0.001). In objective symptom parameters, both FDV and MCC significantly improved after treatment, and DO disappeared in 14 of 35 (40.0%) patients compared to that at baseline (p < 0.01). The voiding function parameters (i.e., mean Qmax, PdetQmax, and PVR) did not significantly change, demonstrating that mirabegron does not inhibit voiding function.

Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2012 Year 05 Month 30 Day

Date of IRB


Anticipated trial start date

2012 Year 07 Month 15 Day

Last follow-up date

2014 Year 03 Month 31 Day

Date of closure to data entry

2014 Year 08 Month 31 Day

Date trial data considered complete

2014 Year 10 Month 30 Day

Date analysis concluded

2014 Year 11 Month 30 Day


Other

Other related information



Management information

Registered date

2015 Year 10 Month 08 Day

Last modified on

2015 Year 10 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022202


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name